Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
ONODERA GT’s Parkinson’s Gene Therapy Gets Sakigake Tag
Japan’s Ministry of Health, Labor and Welfare (MHLW) on June 8 granted sakigake designation to ONODERA GT Pharma’s gene therapy candidate GT0003X for the treatment of Parkinson’s disease.GT0003X was selected for the fast-track program based on its novel mechanism of…
To read the full story
Related Article
- Oncolys’ Telomelysin Wins Backing from Japan Panel
May 22, 2026
- ONODERA GT Pharma Targets 2026 Filings for Two Gene Therapies
February 19, 2026
REGULATORY
- Ishin Proposes Adding Drug, Device Makers to Chuikyo, LDP Wary
June 10, 2026
- Cabinet Approves Immunization Act Revision to Cover Antibody Drugs
June 10, 2026
- LDP Lawmakers Seek Routine HPV Vaccinations for Males by April 2027
June 10, 2026
- LDP Team Seeks Minister-Led AI Task Force at MHLW
June 10, 2026
- MHLW to Continue Reviewing Tavneos Safety Measures: Official
June 10, 2026
Japan’s pharmaceutical industry has become a global business over the past two decades. Overseas markets now make up nearly three-quarters…
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…